The U.S. Food and Drug Administration (FDA) slapped a “Black Box” warning on Chantix (varenicline tartrate, made by Pfizer) in 2009 after receiving thousands of reports linking the drug to mental health issues, including suicidal thoughts, hostility and agitation.

In 2015, the FDA expanded the warning to note that the drug had also been linked to reduced alcohol tolerance leading to seizures.

However, in 2016 the FDA removed the Black Box warning, after heavy lobbying from Pfizer claiming that additional data showed that the benefits of Chantix outweighed its adverse side effects (oh, and since its sales had significantly dropped.)

But the adverse side effects did not go away; only the Black Box warning went away. One study found that Chantix had more cases of suicidal thoughts, self-harm, and homicidal thoughts than any other drug, by a more than three-fold margin. Pfizer’s prescribing information still warns about new or worsening mental health problems such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions while taking or after stopping Chantix.

We suspect that the recent spate of TV ads is related to the removal of the Black Box warning and the prior drop in sales. Also, the price of Chantix more than doubled between 2013 and 2018. In 2013, Pfizer paid out $273 million to settle a majority of the 2,700 state and federal lawsuits that had been filed over adverse side effects. Now the company is trying to grow the market with clinical studies for smokers age 12 to 19.

What is Chantix?

Chantix is a psychiatric drug — a benzodiazepine-based anti-anxiety drug, also called a minor tranquilizer or sedative hypnotic. Daily use of therapeutic doses of benzodiazepines are associated with physical dependence, and addiction can occur after 14 days of regular use. Typical consequences of withdrawal are anxiety, depression, sweating, cramps, nausea, psychotic reactions and seizures. There is also a “rebound effect” where the individual experiences even worse symptoms than they started with as a result of chemical dependency.

The exact mechanism of action of benzodiazepines is not known, but they affect neurotransmitters in the brain and suppress the activity of nerves, under the unproven theory that excessive activity of nerves may be the cause of anxiety. Chantix was developed to specifically affect nicotinic receptors in the brain, under the theory that this would reduce nicotine craving and block the rewarding effects of smoking. Messing with neurotransmitters in the brain is playing Russian Roulette with your mind.

Benzodiazepines are metabolized by cytochrome P450 enzymes, so a genetic lack of these enzymes can cause a buildup of harmful toxins and increase the severity of adverse side effects.

Psychiatric “best practices” consider that smoking is an addiction and recommend that psychiatrists assess tobacco use at every patient visit, since tobacco addiction is covered in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a “mental illness” under eight separate items, and disorders related to inhalant use have 33 entries. Smoking is not a mental illness and addiction cannot be fixed with psychiatric drugs.

The psychiatric industry considers that smoking cessation therapies are their territory, however this drug masks the real cause of problems in life and debilitates the individual, thus denying one the opportunity for real recovery and hope for the future. Treating substance abuse with drugs is a major policy blunder; contact your state and federal representatives and let them know you disapprove of this trend.

Recognize that the real problem is that psychiatrists fraudulently diagnose life’s problems as an “illness”, and stigmatize unwanted behavior like smoking as a “disease.” Psychiatry’s stigmatizing labels, programs and treatments are harmful junk science; their diagnoses of “mental disorders” are a hoax — unscientific, fraudulent and harmful. All psychiatric treatments, not just psychiatric drugs, are dangerous.